Social Media Ideas for 21St Century Cures Act

Nearly 200 Organizations Back Bill to Expand Access to Clinical Trials

Nearly 200 healthcare and patient advocacy organizations endorsed the bipartisan Clinical Trial Modernization Act, which seeks to reduce financial barriers and expand access to cli...

Sen. Committee Clears Drug Disclosure, Biosimilar Bills

The U.S. Senate Committee on Health, Education, Labor and Pensions on Wednesday cleared two bills for full Senate review, tackling the gap between health and patent oversight agenc...

WuXi AppTec’s 1260H Listing Brings the BIOSECURE Act Back to Center Stage

By Steven J. Gonzalez —

Prior authorization reform gets promising start from House health panel

Statement is attributable to: - John Whyte, MD, MPH - CEO, American Medical Association - - “The American Medical Association commends the House Energy and Commerce Health...

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of ex...

Efforts to Authorize Billions to Combat Substance Use Disorder

MONEY CAN HELP – June 25, 2026 –  Today, U.S. Senator Jeanne Shaheen (D-NH), a senior member of the U.S. Senate Appropriations Committee and Ranking Member of the Senate Appropriat...

HHS-OIG Issues Favorable Opinion on Free Companion Diagnostic Test Program for Drug Eligibility

The FDA Opened the Door For Rare Disease Patients — Here’s What It Takes to Walk Through It

The Plausible Mechanism Framework is a breakthrough. Turning it into treatments that reach families will take five things the framework doesn’t provide. The post The FDA Opened the...

McDermott+ Check-Up: June 18, 2026

THIS WEEK’S DOSE Senate Democrats request information on reforming drug pricing. The request for information focuses on lowering prescription drug pricing and out-of-pocket costs...

340B at a Crossroads: What Health Systems Need to Know About Senator Cassidy's Reform Proposal

On June 25, 2026, Senate HELP Committee Chairman Bill Cassidy (R-LA) released a sweeping legislative discussion draft titled the 340B Drug Pricing Integrity and Affordability for P...

CMS Seeks Guidance on Medicare Part D PBM Reform under the CAA 2026

FDA Requests Input on Non-Device Software Functions and Patient Safety; Brief Comment Period Now Open

The U.S. Food and Drug Administration (“FDA”) is seeking public input as it prepares its 2026 report on the risks and benefits to health associated with non-device software functio...

The Foundation Is Built — Now We Must Secure the Future of Interoperability

Patients, providers, and innovators all benefit from secure, trusted, nationwide data exchange. But this trust cannot sustain itself on fragmented governance or competitive enforce...

HHS’s Operation TrialBlazer

On Monday, June 22, 2026, the U.S. Department of Health and Human Services (“HHS”) announced Operation TrialBlazer, a coordinated department-wide initiative aimed at promoting clin...

<![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]>

AMA interoperability initiative brings structured clinical terminology to CPT codes

A new interoperability initiative will begin by targeting prior authorization cases that have the “greatest potential” to reduce administrative burden and aid patients in receiving...

<![CDATA[FDA’s New Pilot Program and Real-Time Review of Clinical Data]]>

Critical Path Institute Unveils New Coalition to Propel Human-Relevant Drug Development Tools

TUCSON, Ariz., and AMSTERDAM — May 19, 2026 — In a transformative step for drug development and regulatory science, the Critical Path Institute (C-Path) has officially launched the...

FDA Reversal on uniQure Gene Therapy Is Another Sign of Renewed Regulatory Flexibility

UniQure is preparing to seek accelerated FDA approval for its Huntington’s disease gene therapy, a move that follows the FDA’s reversal of its prior position calling for another cl...

CMS Announces RAPID Coverage Pathway to Speed Medicare Coverage of New Medical Devices

The Gap Between FDA Authorization and Medicare Coverage In April 2026, the Centers for Medicare & Medicaid Services (“CMS”) and the U.S. Food and Drug Administration (“FDA”) an...

At first public hearing for FDA’s CNPV program, industry support meets ‘deep concern’ from experts

On Thursday, the public had the first chance to air their grievances about the FDA’s controversial Commissioner’s National Priority Voucher (CNPV) pilot program, the flagship initi...

Congress passes 21st Century ROAD to Housing Act, sends bill to Trump

The 21st Century ROAD to Housing Act passed the House of Representatives after clearing the Senate and now heads to President Donald Trump’s desk for signature in the coming days.

Federal health agencies unveil plan to speed up phase 1 clinical trials by 6 to 12 months

As the biotech world flocks to San Diego today for the BIO International Convention, the Department of Health and Human Services has provided plenty of conversation fodder with the...

<![CDATA[New FDA Draft Guidance Targets Gene Therapy Submission Burden by Allowing Use of Existing CMC and Scientific...